Z-0596-2024Class I

Regard Dressing change kit, Item Number 800026006

Name: Z-0596-2024 Regard Dressing change kit, Item Number 800026006
Creator: ROi CPS LLC
Published: 2023-11-20
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2023-11-20 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Regard Dressing change kit, Item Number 800026006 on 2023-11-20. FDA classified it as Class I and gives the reason as "ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0596-2024
Classification: Class I
Status: Terminated
Initiated: 2023-11-20
Posted: 2024-01-03
Terminated: 2024-08-05
Recalling firm: ROi CPS LLC
Product: Regard Dressing change kit, Item Number 800026006
Product code: OXQ Dressing Change Tray
Reason for recall: ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ROi CPS issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 11/27/2023 via email. The notice explained the problem, potential risk, and requested the following actions: 1. CHECK: Please review your inventory to determine if the manufacturer item number and lot numbers listed in the above table are in your inventory. 2. QUARANTINE: Segregate and quarantine all affected kits listed above. Do not further distribute. 3. REMOVE: The affected Cardinal Health item 1022-(100ML Sterile Saline Irrigation bottle), attached to the outside of the affected kits as a piggy back prior to use or further distribution. The remainder of the kit is not affected and can be distributed/used after the 100 ML Saline Irrigation Bottle is removed. 4. REPLY: Please indicate your understanding and completion of the instructions above by completing and returning the attached reply form. a. Complete the section confirming destruction of the sterile saline irrigation bottles removed from the outside of the kit, if applicable, and discard according to your institution's disposal procedures. b. Complete and return the reply form even if you do not have any affected inventory at your facility to acknowledge receipt of the notices. c. Please return the reply form to [email protected]. 5. NOTIFY: Please immediately notify any customers to whom you have distributed or forwarded product affected by this medical device correction notice. You may include a copy of this notice, the notice from Cardinal Health, and the initial recall issued by Nurse Assist in your communication. 6. END USERS: End user facilities are to follow the instructions above and complete and return the reply form indicating their understanding and compliance with the required actions, including the destruction of the Sterile Saline Irrigation Bottles.
Quantity in commerce: 1830 units
Distribution: US Nationwide distribution in the state of Louisiana.
Product codes and lots: UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0596-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0596-2024	Class I	Terminated	Voluntary: Firm initiated	2024-01-10	2024-01-03

Product code OXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)